Senior Quality Assurance Specialist

beBeeQuality; Pavia; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A leading company in genomics, beBeeQuality, is looking for a Quality Assurance Specialist to enhance diagnostic and treatment processes for genetic diseases. This role requires a degree in technical fields and at least 2 years of experience in quality assurance, focusing on compliance with established standards and regulations, including ISO 13485.

Competenze

• At least 2 years of experience in quality assurance.
• Knowledge of IVDR 2017/746 and ISO 13485 standards is required.
• ISO 27001 certification is a strong plus.

Mansioni

• Support in writing and implementing quality system documentation.
• Manage product and process non-conformities and conduct audits.
• Train staff and monitor KPIs.

Conoscenze

Communication

Quality Assurance

Attention to Detail

Problem Solving

Training

Formazione

Degree in technical or scientific fields

Strumenti

Office suite

Descrizione del lavoro

We are seeking a skilled professional to enhance the diagnosis and treatment of genetic diseases through the use of genomic information. Our mission is to leverage artificial intelligence and bioinformatics to guide our development, bringing innovative solutions to market.

Main Responsibilities :

• Support in writing, updating, and implementing quality system documentation in accordance with applicable standards.
• Manage product, process, system, audit non-conformities by writing supporting documentation and involving in internal investigation for root cause determination.
• Plan, manage, and monitor corrective and preventive actions defined by the company.
• Maintain quality registrations and documentations under control.
• Support in activities related to writing, updating business process risk analysis.
• Train staff and gather evidence of training.
• Monitor processes and KPIs.
• Communicate and cooperate with other departments.
• Support auditing activities, internal or versus suppliers, and perform internal audits in accordance with the annual audit plan.
• Requirements and Skills :
• Degree in technical or scientific fields.
• At least 2 years of experience in quality assurance.
• Knowledge of standards and regulations applicable to the type of activity (IVDR 2017 / 746, ISO 13485).
• Experience in quality systems audit according to ISO 13485.
• ISO 27001 is a strong plus.
• Aptitude to contact suppliers, consultants, and partners.
• Ability to interface with different departments.
• Knowledge of Office suite.
• Good written and spoken English.

This role offers an opportunity to work on enhancing medicine and healthcare through genomics, contributing to the development of innovative solutions that make a difference in people's lives.

Quality Assurance Specialist • Pavia, Lombardia, Italia